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Cell Therapy Enforcement Discretion Ending, But US FDA Still Faces Challenge Going After Bad Actors

 
• By Sarah Karlin-Smith

Planned 31 May revocation of enforcement discretion for certain cell therapy products without IND or BLA is important, but experts say the FDA’s next moves are what will really shape the field and patient safety moving forward.

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Stem cell experts say the ball is now in the FDA’s court to remove bad actors from the market. • Source: Shutterstock

The US Food and Drug Administration will end a more than three-year grace period for certain regenerative medicine products to comply with the agency’s investigational new drug and premarket approval requirements on 31 May.

Experts in the field say the agency’s next steps will be crucial to determining whether the “broad marketing of these unapproved products” as acknowledged by FDA in its

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